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A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

NCT05120349 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-04-23

No results posted yet for this study

Summary

This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.

Conditions

Interventions

DRUG

Osimertinib

The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease recurrence, unacceptable toxicity or other discontinuation criteria are met.

DRUG

Placebo

Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.

Sponsors & Collaborators

Principal Investigators

  • Jonathan Goldman, MD · University of California, Los Angeles

  • Yasuhiro Tsutani, MD, PhD · Kindai University Facility of Medicine

  • Jie He, MD, PhD · The Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2027-08-02
Completion
2032-11-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • China
  • Germany
  • Italy
  • Japan
  • Malaysia
  • Poland
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05120349 on ClinicalTrials.gov